Bioretec is accelerating its U.S. commercialization efforts behind RemeOs, the first and only FDA-authorized absorbable metal implant commercially available in the United States.
OTW recently spoke with Sarah Hubar-Fisher, who transitioned from a board member role to interim CEO before becoming permanent CEO, to get an update on where the company stands.
RemeOs is a magnesium-based implant designed to actively promote native bone regrowth as it degrades. The company received FDA authorization for the osteopromotion claim, which distinguishes the product from every other absorbable implant on the market. Receiving this claim was no small feat, as many within the orthopedic community have questioned whether this technology would ever receive that designation from the FDA.
In Q4 2025, CMS granted Transitional Pass-Through Payment status to the RemeOs Trauma Screw, creating a first-of-its-kind C-code for absorbable metallic bone fixation. Shortly after, the FDA granted Breakthrough Device Designation to the RemeOs DrillPin, the company’s third such designation and the first ever awarded to an absorbable implant company.
On the commercial side, Bioretec moved away from a stocking distributor model and transitioned to direct distribution in the U.S. in 2025, reporting three consecutive quarters of direct sales growth. Growth is trending in the right direction, though Sarah is quick to point out that the work is far from done. One screw is not a portfolio. The company’s near-term priority is accelerating the pipeline, with a target of launching a new product every 12 to 18 months.
According to Sarah and team, surgeon feedback is encouraging. Surgeons are no longer asking why they should consider an absorbable implant but rather want to understand the material science and the usability of these unique implants. In Sarah’s words, “Every conversation is about the degradation time, how the material performs, have you had any late stage events. They all want to understand the strength, the stiffness, the flexibility. That’s really where we’re focusing.”
